Alcohol Use DisorderIMPACT-ALDNCT06305624
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
A study testing Connections App in people with Alcohol Use Disorder and Alcohol-related Liver Disease, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol-related Liver Disease
- What is being tested?
- Connections App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ALD (any stage)
- Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.
- Alcohol use within the last 6 months
- Receiving care at UW or Henry Ford Health + MSU
- Either the general hepatology clinic or the multidisciplinary ALD clinic
- Able to read and write proficiently in English
- Willing and able to use a smartphone app
Who cannot join
- Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
- In hospice care
- Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Henry Ford + Michigan State University Health Center
Lansing, Michigan, 48824
- Recruiting
UW General Hepatology Clinic
Madison, Wisconsin, 53705
- Recruiting
UW Multidisciplinary ALD Clinic
Madison, Wisconsin, 53705
About this study
Official title: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.
Read the detailed description
The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function.
- Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months.
- Aim 2: Assess the implementability of the Connections app in the ALD population using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels.
Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.
- Being tested
- Connections App
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connections AppDevice
mobile application, a place where participants can find community and support to help them manage their ALD, learn liver health self-care, coping skills, and alcohol abstinence strategies.
| Study group | Role | What they receive |
|---|---|---|
| Connections App | Experimental | The Connections app is based on principles of effective care for substance use disorders, such as sustained duration, peer support, improving coping skills in high-risk situations, assertive outreach, self- monitoring, prompts, and action planning. The theoretical foundation of CHESS Health is self-determination theory, which holds that an individual's adaptive functioning can be improved if the patient feels (1) competent, (2) related to others, and (3) internally motivated rather than coerced in one's actions. Receives: Device: Connections App |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Alcohol Abstinence in ALD Participants
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
Measured: data collected monthly, up to 6 months
Number of Standard Drinks Consumed in ALD Participants
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days, if yes, participant's will also be asked the number of standard drinks for each day alcohol was consumed. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
Measured: data collected monthly, up to 6 months
Secondary outcomes (11)
Change in Patient Health Questionnaire (PHQ-8) Score
The PHQ-8 score is a measure of depressive symptoms that ranges from 0 to 24 where higher scores indicate increase depression.
Measured: baseline, 3 months, 6 months
Change in PROMIS Global Health Score
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score is a measure of quality of life. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health Score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: baseline, 3 months, 6 months
Change in Generalized Anxiety Disorder (GAD-7) Score
GAD-7 is a measure of anxiety and has a range of scores from 0-21 where higher scores indicate increased anxiety.
Measured: baseline, 3 months, 6 months
Change in Insomnia Severity Index (ISI) Score
ISI is a measure of insomnia and has a range of scores from 0-28 where higher scores indicate increased insomnia.
Measured: baseline, 3 months, 6 months
Change in Pain Interference (PEG) Score
PEG is a pain measure scored from 0 (no pain or interference) to 10 (worst pain and complete interference).
Measured: baseline, 3 months, 6 months
Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score
DMQ-A is a measure of drinking motivations, scored from 1-5 in each of 5 domains: social, coping, confidence, taste, enhancement. Higher scores indicate higher motivation to drink.
Measured: baseline, 3 months, 6 months
Change in CHESS Bonding Scale Score
The CHESS Bonding Scale is an adapted measure developed to "capture the concept of universality, group cohesiveness, and informational and emotional support". Score from 0 to 20 where higher scores indicates increased bonding.
Measured: baseline, 3 months, 6 months
Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score
DTCQ-8A is a measure of self-efficacy scored from 0-100 where higher scores indicate greater self-efficacy.
Measured: baseline, 3 months, 6 months
Change in Treatment Self-Regulation Questionnaire (TSRQ) Score
TSRQ is a measure of self-regulation scored from 1 to 7 in each of 4 domains: autonomous motivation, introjected regulation, external regulation, amotivation. Higher scores indicate more self-regulation.
Measured: baseline, 3 months, 6 months
Alcohol Use Disorders Identification Test (AUDIT-10)
AUDIT-10 is a measure of participant use of alcohol to score risk level. Total range of scores is from 0-40 where higher scores indicate higher risk level. [0-7 = Risk level I, 8-15 = Risk level II,16-19 = Risk level III, 20-40 = Risk level IV]
Measured: baseline, 6 months
CHESS Bonding Scale
CHESS Bonding Scale captures app users' ability to connect with the ALD community via the app about ALD, rather than drinking behaviors. Total range of scores is 0-20 higher scores indicate higher connection to the community.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jun 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, Type 1 hybrid implementation-effectiveness trial.
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Andrew Quanbeck, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305624
- Sponsor's protocol ID
- 2024-0130
- Other IDs
- 1R01AA030470-01A1, A532000, Protocol Version 4/23/26
- Acronym
- IMPACT-ALD
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant-level data that have been de-identified will be deposited and made available in a data repository maintained by NIAAA and referenced as NIAAA-DA. The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) is a data repository that houses and shares human subjects' data generated by NIAAA-funded research. Data released through NIAAA-DA are assigned a citation that includes a Global Unique Identifier (GUID). The GUID is a unique persistent identifier maintained by NIAAA-DA to ensure the data can be permanently identified. The citation and GUID are available on the study page and are provided with each download.
Publications
He C, Edwards J, Park LS, Herzog M, Li X, Pulvermacher A, Mundt MP, Brown R, Mellinger J, Quanbeck A. Implementation of Mobile-Based Programs for Alcohol Cessation in the Treatment of Alcohol-associated Liver Disease: Protocol for a Type 1 Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2026 May 29;15:e94231. doi: 10.2196/94231.
PubMed 42214070
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
- ClinicalTrials.gov ID
- NCT06305624
- Acronym / sponsor ID
- IMPACT-ALD / 2024-0130
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.
Detailed description
The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function.
- Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months.
- Aim 2: Assess the implementability of the Connections app in the ALD population using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels.
Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, Type 1 hybrid implementation-effectiveness trial.
| Arm | Type | Receives |
|---|---|---|
| Connections App | Experimental | Device: Connections AppThe Connections app is based on principles of effective care for substance use disorders, such as sustained duration, peer support, improving coping skills in high-risk situations, assertive outreach, self- monitoring, prompts, and action planning. The theoretical foundation of CHESS Health is self-determination theory, which holds that an individual's adaptive functioning can be improved if the patient feels (1) competent, (2) related to others, and (3) internally motivated rather than coerced in one's actions. |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of ALD (any stage)
- Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.
- Alcohol use within the last 6 months
- Receiving care at UW or Henry Ford Health + MSU
- Able to read and write proficiently in English
Key exclusion criteria (3 listed)
- Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
- In hospice care
- Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connections Appmobile application, a place where participants can find community and support to help them manage their ALD, learn liver health self-care, coping skills, and alcohol abstinence strategies. | Device | Connections App |
Primary outcome
Days of Alcohol Abstinence in ALD Participants
Time frame: data collected monthly, up to 6 months
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
Number of Standard Drinks Consumed in ALD Participants
Time frame: data collected monthly, up to 6 months
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days, if yes, participant's will also be asked the number of standard drinks for each day alcohol was consumed. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
11 secondary outcomes
Change in Patient Health Questionnaire (PHQ-8) Score
Time frame: baseline, 3 months, 6 months
Change in PROMIS Global Health Score
Time frame: baseline, 3 months, 6 months
Change in Generalized Anxiety Disorder (GAD-7) Score
Time frame: baseline, 3 months, 6 months
Change in Insomnia Severity Index (ISI) Score
Time frame: baseline, 3 months, 6 months
Change in Pain Interference (PEG) Score
Time frame: baseline, 3 months, 6 months
Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score
Time frame: baseline, 3 months, 6 months
Change in CHESS Bonding Scale Score
Time frame: baseline, 3 months, 6 months
Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score
Time frame: baseline, 3 months, 6 months
Change in Treatment Self-Regulation Questionnaire (TSRQ) Score
Time frame: baseline, 3 months, 6 months
Alcohol Use Disorders Identification Test (AUDIT-10)
Time frame: baseline, 6 months
CHESS Bonding Scale
Time frame: baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 42214070He C, Edwards J, Park LS, Herzog M, Li X, Pulvermacher A, Mundt MP, Brown R, Mellinger J, Quanbeck A. Implementation of Mobile-Based Programs for Alcohol Cessation in the Treatment of Alcohol-associated Liver Disease: Protocol for a Type 1 Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2026 May 29;15:e94231. doi: 10.2196/94231.
- Individual participant dataSharing planned: Yes. Participant-level data that have been de-identified will be deposited and made available in a data repository maintained by NIAAA and referenced as NIAAA-DA. The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) is a data repository that houses and shares human subjects' data generated by NIAAA-funded research. Data released through NIAAA-DA are assigned a citation that includes a Global Unique Identifier (GUID). The GUID is a unique persistent identifier maintained by NIAAA-DA to ensure the data can be permanently identified. The citation and GUID are available on the study page and are provided with each download.
Related trials for Alcohol Use Disorder
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Quanbeck, PhD principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connections App in people with Alcohol Use Disorder and Alcohol-related Liver Disease, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared P McDonald, MBA (608-263-4022, jared.mcdonald@fammed.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Alcohol Abstinence in ALD Participants (time frame: data collected monthly, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.